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UroViu gets FDA 510(k) clearance for single-use cystoscope

Published 16 March 2018

UroViu has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Uro-V single-use diagnostic cystoscopic system.

Additionally, the United States Patent and Trademark Office has issued a patent to UroViu on the Uro-V System. The single-use disposable, semi-flexible, easy-to-use and patient-friendly Uro-V System represents a major advance in diagnostic cystoscopy.

It is estimated that more than 4 million cystoscopic procedures are performed every year worldwide [1][2]. Diagnostic cystoscopy is the most common procedure and the standard of care used to visually assess the urethra and the urinary bladder in instances of suspected pathology or dysfunction.

Standard cystoscopy uses either flexible (most frequently in North America) or rigid (most frequently globally) cystoscopes, which have been the bottleneck of urology practices because (1) they are bulky and require a dedicated procedure room and long setup time, (2) they have downtime because they need to be sterilized and reprocessed between patients, and, (3) they are expensive to own, maintain and repair.

There are significant patient compliance issues due to complexity and discomfort with today's cystoscopic procedures. Furthermore, as the currently available cystoscopes are reusable, the issue of reprocessing and disinfection between patient uses is critically important, especially in the light of reported "super bugs" and cross-contamination with highly resistant organisms by endoscopes in urology, as well as other therapeutic areas.

Many professional societies, including the American Urological Association, and endoscope manufacturers have strict reprocessing guidelines in place.

Even though flexible cystoscopes are considered semi-critical devices, in light of recent reports of scope-associated infection, there is movement to reclassify them as critical devices. Since high-level disinfection is not considered adequate for reprocessing, formal sterilization is expected to be required following each use in the very near future.

Uro-V is a self-contained, off-the-shelf, single-use diagnostic cystoscope specifically designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency.

Uro-V is a light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that includes video processor, LCD display, and touch panel user interface. The cannula is hydrophilic coated with an outer diameter of 12 Fr. and has a 140-degree field-of-view camera, with 30-degree deflection and LED illumination module at its tip and a shared single channel for fluid infusion.

A prospective, observational, single-arm, open-label clinical usability study in subjects who were candidates for office diagnostic cystoscopy has been completed at 2 centers in the USA and a center in Europe (OUS). Cystoscopy with this new system was performed in 64 female subjects who were candidates for diagnostic cystoscopy, who were willing and able to provide consent.  All procedures were completed without incident and no adverse reactions were reported.

University of California San Francisco professor and vice chair of the department of urology Marshall Stoller said: "Today's growing and aging population faces a severe problem of an increasing shortage of urologists.

“The Uro-V Cystoscope has great potential to make the standard urological care more accessible and convenient for the patients while greatly reducing the burden of the urologists and staff."

In conclusion, Uro-V substantially reduces the risk of cross-contamination, while providing superior optics, unmatched portability and tolerability and allows for cystoscopy to be performed in any room and anytime.



Source: Company Press Release